Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

项目概要/摘要： 为了应对阿片类药物滥用和成瘾的国家公共卫生危机，国家 美国卫生研究所（NIH）于2011年启动了HEAL（帮助结束长期成瘾）计划。 2018年4月，积极推动科学工具的开发，以结束阿片类药物危机 通过加快有效的发现通过FDA的药物批准。HEAL倡议 在未来五年的发展计划，预计将导致15个新的研究 药品（IND）申请和至少5个新药申请（NDA）。美国国立卫生研究院治愈 该倡议在国家药物滥用研究所（NIDA）下发布了本RFA-DA-19-002， “支持发现和开发预防和治疗阿片类药物使用的药物 疾病（OUD）和过量。 深圳市华诚发展有限公司（INDUSTRY）开发了大麻二酚口服溶液， 显示出作为预防复发的新型药物的前景， 改善治疗方案的机会（机会4）。在合作中， 与KAI Research，Inc.计划启动大麻二酚效应的临床开发计划 关于预防阿片类药物使用障碍的渴求和复吸的报告， UG 3/UH 3阶段的临床试验： 1.对于UG 3阶段，INFERRED与主要研究者Edythe伦敦博士合作 （加州大学洛杉矶分校）将进行一项随机、双盲、安慰剂对照、剂量范围研究， 大麻二酚口服溶液对线索诱导的渴望，戒断的调节， OUD患者的负面情感状态、阿片类药物使用复发和治疗保留 在住院戒毒所接受丁丙诺啡治疗的结果 这项研究将用于支持向UH 3阶段的过渡。 2.对于UH 3阶段，INFERRED与主要研究者Kathleen布雷迪，MD， 博士（MUSC）将在门诊环境中进行两项研究： ·大麻二酚口服给药的随机、双盲、安慰剂对照、平行组研究 胶囊作为丁丙诺啡±纳洛酮的替代治疗，用于治疗 阿片类药物使用障碍 ·一项随机、双盲、活性对照、平行组、双模拟、 大麻二酚口服胶囊与纳洛酮作为单一治疗的概念研究 阿片类药物使用障碍患者的治疗。

Project Summary/Abstract: In response to the national public health crisis of opioid misuse and addiction, the National Institute of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative in April 2018 to aggressively drive the development of scientific tools that will end the opioid crisis by accelerating effective discoveries through the FDA for drug approval. The HEAL Initiative development programs over the next five years are expected to result in 15 Investigational New Drugs (INDs) applications and at least 5 New Drug Applications (NDAs). The NIH HEAL Initiative has issued this RFA-DA-19-002 under the National Institute on Drug Abuse (NIDA) to “support the discovery and development of medications to prevent and treat opioid use disorders (OUD) and overdose.” INSYS Development Company, Inc. (INSYS) has developed cannabidiol oral solution, which shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified to improve treatment options (Opportunity 4). INSYS, in collaboration with KAI Research, Inc., plans to initiate the clinical develop program of Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder consisting of three proposed clinical trials under the UG3/UH3 Phases: 1. For the UG3 phase, INSYS in collaboration with principal investigator Edythe London, PhD (UCLA) will conduct a randomized, double-blind, placebo controlled, dose-ranging study of cannabidiol oral solution on cue-induced cravings, modulation of withdrawal, alteration in negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this study will be used to support the transition to the UH3 phase. 2. For the UH3 phase, INSYS in collaboration with principal investigator Kathleen Brady, MD, PhD (MUSC) will conduct two studies in an outpatient setting: • A randomized, double-blind, placebo-controlled, parallel-group study of cannabidiol oral capsule as adjunctive therapy to buprenorphine ± naloxone for treatment in patients with opioid use disorder. • A randomized, double-blind, active-controlled, parallel-group, double-dummy, proof-of- concept study of cannabidiol oral capsule compared to naltrexone as monotherapy for treatment in patients with opioid use disorder.